Dr Rajeev Raghuvanshi, ET HealthWorld

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By Devanshi Dewan & Prabhat Prakash

Mumbai: The trajectory of the Indian pharmaceutical industry has been one of the most expansive and prosperous in the recent past. From embracing technological advances and incorporating them to driving the healthcare and pharma industry, India has been at the forefront of innovative practices that have rapidly led to achievements in the pharma sector, so much so that currently India is a global leader when it comes to manufacturing and supplying pharmaceuticals.

The 4th edition of the REPharma Summit, themed ‘Reinvent, Restructure, and Reform’, featured an insightful valedictory address by Dr Rajeev Singh Raghuvanshi, Drug Controller General of India (DCGI), which was the perfect conclusion to the summit. Dr Raghuvanshi talked about the achievements the Indian pharmaceutical industry has achieved and expressed his aspirations for the industry to reach the predicted growth rate target by 2030.

Initiating the address, Dr Raghuvanshi acknowledged the topics of the panel discussions that took place at the event. He mentioned that the topics were extremely relevant and contemporary in significance, encompassing artificial intelligence (AI), quality metrics, and supply chain dynamics.

He emphasised the various steps Indian leaders in the pharmaceutical industry need to adopt for the country to compete globally. In that regard, he mentioned the role MSMEs play and how pertinent it is today to give impetus to these enterprises, as they form the backbone of any economy.

He stated, “The IP members have a big responsibility to take along the small brothers, which we currently call MSMEs in this country. I differ from one aspect in that this country has two extremes. When you talk about all these topics of quality, supply chain, and AI, you might be looking at one extreme. Where there is competence, there is a will, and there is a skill to do all this.”

He pointed out the target that India is seeking to achieve by 2030. He said, “Currently, we are at $50 billion, and the target is about $130 billion in the next seven years. And we also know that it will not come from generics, increasing the volume of generics. It will only come if we innovate the product process. Whatever it is, it won’t come without innovation. Innovation cannot be and will never be successful if it is happening in pockets. It has to be a mass movement.”

Dr Raghuvanshi pointed out the efforts by the government to accelerate the growth rate to reach the target India has set for itself.

He mentioned, “The government is doing a lot to support that ambition. If you see from the policy front, at the investment front, a lot is happening. With the R&D policy, the infrastructural support for the API parks, medical device parks, and pharma parks, creating knowledge centres, and upgrading capability, connecting different institutes with capabilities to bring out innovations. The government is pushing the agenda of volume to value, which will come through only innovation. And the responsibility is also on all of us to take that agenda forward, help governments push it, and translate it into measurable products and outcomes. At the regulatory end, if you see, a lot is happening.”Citing examples of advanced regenerative therapies like CAR-T cell therapy, gene therapy and biologics are some of the milestones India has been able to achieve, putting it at the forefront of healthcare advancements globally.

He stressed the need to incorporate innovation and sustainability and change the mindset the industry has to drive developments at an even more rapid pace. He shared the various ways in which the industry can go about achieving that and also emphasised the eradication of the spurious drug trade in the country.

He stated, “My request to people like you is to propagate that, to the extent possible, so that it gets implemented on the ground. The first one is the QR code system on APIs. When it comes to putting QR codes on API packs and API drums, the simple requirement is that you should put a QR code that can be traced back, which brings traceability to the API from origin to end. We have to implement a QR code on APIs, as it has the potential to completely remove the spurious API trade in this country. Whatever is happening is happening only because there is no traceability. So if we can religiously implement this barcode system, this is going to completely change that whole dynamic. The second one is on the QR code to be put on the top 300 brands of this country. Our data shows that 90 per cent plus spurious trade happens in these top 300 brands. If we can put a robust QR code on this, it has the potential to completely remove spurious trade. And for that, the public has to be made aware, and the retailer has to be made aware.”

“On the other hand, if we can successfully implement the kinds of provisions we have put in the revised curriculum, it is at par almost with the WHO GMP requirements, and most of the US FDA requirements have been put in. If we are able to do that, it is going to change the whole face of the manufacturing industry. That is what is required today if we have to succeed on the global platform, and what is probably going to be the game changer is the digital drug regulatory system, for which we have started the process of selecting the proper vendor to develop that digital ecosystem. So that we can, sitting in Delhi, actually monitor what is happening throughout the country when it comes to the supply chain, manufacturing, sourcing, sales, etc. It will have potential, like the income tax system. If fully operational, it can change the complete face of the regulatory system in this country,” he added.

Concluding his address at the REPharma Summit 2024, Dr Raghuvanshi applauded the change that has come within the industry when it comes to internal accountability and responsibility in the regulatory framework. He conveyed that India is already moving in the right direction and that the massive potential the pharmaceutical industry has can be harnessed perfectly by growing our MSME sector and changing the trajectory of development by fueling innovation.

  • Published On Jan 29, 2024 at 01:28 PM IST

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